Kornimate/medical-research-clean huggingface dataset:
prevention of intrauterine growth retardation in burkina faso: the malaria component

Conditions: Malaria; Malaria in Pregnancy

Summary: our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. this study was carried out !in the same population recruited for the iugr study (nct00642408).

a research project aiming at investigating the impact of multivitamin-mineral supplementation (mms) during pregnancy on intra-uterin growth retardation was carried out in the hounde district, an area not far from the centre muraz located in bobo dioulasso, and where malaria is endemic. malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia. the administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. however, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. it has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage. an alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. moreover, the incidence of malaria clinical episodes during sp intermittent preventive treatment has never been investigated. therefore, this open label, factorial study was carried out in the same women recruited for the iugr nutritional study (nct00642408). women receiving multiple micronutrients supplements (mms) or dietary supplements (ifa) were further randomised in 2 groups: cq weekly chemoprophylaxis or sp intermittent preventive treatment. the administration of treatment was directly observed.

Eligibility criteria:
inclusion criteria: * 15 to 44 years * females * living in the study area exclusion criteria: * planning to move outside the district within two years * regularly using a contraceptive methods * already pregnant at the start of the trial

Keywords: malaria pregnancy prevention chloroquine sulphadoxine pyrimethamine maternal anaemia birth weight foetal anaemia
reducing cardiovascular disease risk factors in rural communities in north carolina

Conditions: Cardiovascular Diseases

Summary: the study will determine the feasibility and efficacy of adapting an evidence-based intervention (ebi) to reduce cardiovascular disease (cvd) risk factors in rural african american communities and determine the acceptability of mobile technology in these communities to support behavior change.

cardiovascular disease (cvd), the leading cause of death in the united states (us), disproportionately burdens rural communities. cvd prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the us. the proposed settings for this research report similar trends in cvd prevalence, where cvd and stroke are among the top three leading causes of death. in community health assessments conducted in the last three years cvd risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. these disparities are likely to widen; at the current rate, its estimated 50% of individuals in the us will have cvd by 2030. using a community-based participatory research (cbpr) approach, our specific aims for the study are to: 1. expand and sustain a coalition of community and academic stakeholders to develop successful cvd risk prevention strategies in rural communities; 2. conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of cvd data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of cvd risk reduction ebis and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of ebi acceptability; 3. adapt premier, a multi-component ebi using intervention mapping; 4. conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted premier in rural settings.

Eligibility criteria:
inclusion criteria: * african american * aged 21 and older * has at least one of the following cardiovascular disease (cvd) risk factors: pre-diabetes, hypertension, obesity, family history of early cvd, prior cvd * reside in nash or edgecombe counties of north carolina exclusion criteria: * evidence of active or unstable cvd * cognitive impairment that limits informed consent

Keywords: cardiovascular diseases community-based participatory research african americans
pavs in cardiology

Conditions: Cardiovascular Diseases

Summary: brief summary this is a pilot study implemented physical activity assessment, promotion and monitoring in patients. patients will be assessed by the physical activity vital sign (pavs) during check-in for their appointment. during their visit with the cardiologist, a clinical decision support tool will alert the cardiologist to patients achieving low (\<50% of recommended) physical activity. the cardiologist may refer the patient to cardiac rehabilitation if appropriate and/or counsel them to increase their physical activity levels. the patients may opt to enroll in the monitoring phase of the study. they will be given a fitbit pedometer and their fitbit account can sync to their mychart account. after that sync, the patients step counts will be available for their cardiologists to review as needed.


Eligibility criteria:
inclusion criteria: adult patients in the center who are age 18 and above will be assessed with the pavs as part of routine care. to enroll in the home monitoring of pa: 1. patients must achieve \< 50% of pa recommendations according to pavs screening questions 2. have a cellular phone with data plan or a computer to sync fitbit data 3. speak english or spanish 4. be willing to wear a fitbit zip for 3 months exclusion criteria: 1. adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina) 2. planned surgery within three months 3. those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis) 4. pregnant or breastfeeding women.
exercise training and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the present study aimed to determine the effects of 16 weeks of aerobic interval training on quality of life and a set of clinical biomarkers.

besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure, central obesity and dysglycemia) subclinical disorders related to chronic inflammation and cell damage have been reported on metabolic syndrome. therefore, regarding the systemic feature of metabolic syndrome, we investigated an new approach of aerobic interval training on several clinical biomarkers widely used. such training used differs from current aerobic protocols in order to attenuate metabolic and musculoskeletal overload on untrained and unhealthy subjects.

Eligibility criteria:
inclusion criteria: * having metabolic syndrome according to international diabetes foundations definition (idf). * age between 35 - 60 years and untrained subjects. exclusion criteria: * musculotendinous or osteoarticular injuries in the lower limbs and/or spine * chronic pulmonary diseases * neurological disorders * kidney failure * high-risk cardiovascular diseases (unstable angina pectoris, uncompensated heart failure, complex ventricular arrhythmias or myocardial infarction during the last month).

Keywords: aerobic interval training biomarkers
clinical evaluation of a silicone hydrogel lens

Conditions: Myopia

Summary: the purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.


Eligibility criteria:
inclusion criteria: * currently wearing lotrafilcon a lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months. * removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner. * able to achieve distance visual acuity of at least 20/40 in each eye with study lenses. * other protocol inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within 12 months prior to enrollment. * currently enrolled in any clinical trial. * history of corneal refractive surgery. * other protocol inclusion/exclusion criteria may apply.
overcoming treatment barriers

Conditions: Health Care Utilization; Health Care Seeking Behavior

Summary: this study aims to assess whether negative or rather the lack of positive treatment expectations could be positively influenced by online short interventions and increase intention so seek treatment and actual help-seeking behavior when compared to a no-treatment control group. further, the study investigators like to explore if specifically focusing on intensifying positive treatment expectations vs. a reduction of expectations about negative treatment effects will influence the pattern of results differently.

the investigators expect that participants receiving an intervention e.g., amplifying positive (performance) expectancies vs. reducing negative (performance) expectancies of psychotherapeutic treatment, will show an increase in intentions to seek treatment and are more likely to report actual treatment-seeking behavior after the intervention when compared with participants who will describe their treatment expectations via a writing task. further, the investigators want to explore if the expectancy-modulating interventions will differently affect the intention to seek treatment within socially anxious individuals. if participants agree, the investigators plan to assess changes in expectations, attitudes as well as actual treatment seeking behavior at a follow-up assessment one week later (data from follow-up will be analyzed exploratively and is not part of the main hypotheses).

Eligibility criteria:
inclusion criteria: * at least 18 years old * fluent in german (c level) * access to a computer device with internet access exclusion criteria: * non correctable hearing or visual impairment * current in psychotherapeutic treatment or on a waiting list * no neurological impairment or psychotic disorders
navah impact on radiation therapy completion in black breast & prostate cancer patients

Conditions: Breast Cancer; Prostate Cancer

Summary: african-americans have disparately limited access to optimal cancer care. they have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the united states. elucidation of disparities in access to cancer care are important since previous work has indicated that when equal access to rt in radiation therapy oncology group (rtog) prospective randomized trials is granted, race does not independently affect outcomes, a finding similar to work conducted in level i evidence-proven optimal management of curable neurologic conditions. breast cancer is the most common cancer in african-american women and prostate cancer is the most common cancer in african-american men. african-american breast \& prostate cancer participants are less likely to receive standard-of-care radiation therapy. previous work has identified that compared to caucasian women with breast cancer, african-american women are 48% more likely to have rt omission during treatment, 167% less likely to receive timely completion of rt after breast-conserving surgery, 40% less likely to complete rt, and significantly more likely to experience rt treatment delays. shorter course radiation therapy may reduce disparities in radiation therapy care facing african-american breast cancer participants.


Eligibility criteria:
inclusion criteria: * subjects must have histologically or cytologically confirmed breast or prostate cancer. * subjects must be age \>18 years. this study requires informed consent by the subject; as children are not able to perform this without parental approval, subjects \< age 18 are excluded from this study. * subjects must be of african - american race. * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * subjects not of african - american ethnicity. * subjects without histologically or cytologically confirmed breast or prostate cancer.

Keywords: radiation therapy navigator-assisted hypofractionation
meditation for post stroke depression

Conditions: Stroke; Depression

Summary: the purpose of this study is to establish the feasibility and acceptability of a breath-based meditation in stroke survivors with post-stroke depression (psd) and their informal caregivers, as well as to examine the effects of the breath-based meditation. the hypothesis is that the breath-based meditation will lead to decreases in the severity of symptoms of psd, post-stroke anxiety (psa), and post-traumatic stress disorder (ptsd), and decreases in plasma il-1 pro-inflammatory cytokines post-intervention in stroke survivors with psd and their informal caregivers.


Eligibility criteria:
inclusion criteria: * stroke survivors will be included if they speak english, can provide written informed consent, have a history of ischemic stroke, hemorrhagic, or transient ischemic attack within the past 8 weeks, have a center for epidemiologic studies-depression (ces-d) total score of 16 or greater suggestive of clinically significant depressive symptoms, and currently live at home. * informal caregivers will be included if they are speak english, can provide written informed consent, and self-identify as a first-time informal caregiver of a stroke survivor. - * to reflect standard practice, stroke survivors and their informal caregivers will be eligible to participate in the study regardless of whether they are currently receiving anti-depressant medications; however, the dose must have been stable for at least one month prior to recruitment into the study. exclusion criteria: * stroke survivors will be excluded if they currently reside outside of the home (e.g., rehabilitation center). * stroke survivors and their informal caregivers will be excluded if they have severe cognitive impairment (montreal cognitive assessment (moca) cutoff score of 20), active psychosis, or bipolar disorder; if they currently abuse substances; or if they are acutely suicidal. those currently receiving formal psychotherapy or currently engaging in self-identified meditation practices will also be excluded.
status of people with cerebral palsy and their caregivers during covid-19 pandemic

Conditions: Cerebral Palsy

Summary: covid-19, as well as the collateral situations that it entails, has been causing panic, anguish and anxiety that has generated biopsychosocial problems in society affecting not only the physical and social level but also the mental health and well-being. the main objective of this research project is to assess the biopsychosocial status of people with cerebral palsy and related diseases and their caregivers during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * cerebral palsy patients and their caregivers exclusion criteria: * patients or caregivers with cognitive impairment
deciphering the role of incretin hormones in weight loss-induced remission of type 2 diabetes (diabeat)

Conditions: Obesity; Diabetes Mellitus Type 2 in Obese

Summary: the goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.

participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. before and after the intervention, the patients will undergo: * measurement of fasting glucose and glycated hemoglobin * indirect calorimetry * oral glucose tolerance test * intravenous glucose tolerance test * quality of life and diet-related questionnaires * 72-hour food records at the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.

Eligibility criteria:
inclusion criteria: * t2d for less than 6 years; * age 18-65 years; * both genders; * bmi 27-45 kg/m2; * hba1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs). exclusion criteria: * type 1 or secondary/genetic diabetes; * treatment with insulin, glucagon-like peptide-1 agonists, gastric inhibitory peptide/glp-1 co-agonists, or pioglitazone; * weight loss \>5% within the previous 6 months; * egfr \<30 ml/min/1.73m2; * myocardial infarction within the previous 6 months; * severe heart failure (nyha iii-iv); eating disorder; substance abuse; * severe depression; * known cancer; * pregnancy.
reproducibility of virtual exercise assessments versus face-to-face exercise testing in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: rexa-cf is investing if results from exercise tests (the chester step test and the one-minute sit-to-stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. the study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the chester step test). the two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. one session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. after the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis (as confirmed by standard criteria) * sixteen years of age or over * home internet access * stable cf disease as judged by the medical team * registered with the royal brompton hospital adult cf team exclusion criteria: * inability to give consent for treatment or measurement * current participation in another interventional study * current moderate haemoptysis (greater than streaking in the sputum) * pregnancy * forced expiratory volume in 1 second (fev1) below 30% predicted * dependency upon oxygen therapy (with home oxygen concentrators or portable oxygen cylinders) or non-invasive ventilation (niv) * current neurological or musculoskeletal injury which would prevent completion of exercise tests * inability to complete the second set of exercise tests within three weeks

Keywords: exercise testing
treatment of pd-1 inhibitor in aids-associated pml

Conditions: Progressive Multifocal Leukoencephalopathy; AIDS

Summary: pd-1 inhibitor （pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usage）treatment on aids patients with progressive multifocal leukoencephalopathy.

this is a one-center, single-arm and prospective study, planing recruiting 10 aids-associated pml patients. all patients will receive pd-1 inhibitor (pembrolizumab) for 12 weeks, and the dose for each time is 2 mg per kg/weight, and the frequency is once per 4 weeks. the effect and safety of pembrolizumab on aids-associated pml will be evaluated.

Eligibility criteria:
inclusion criteria: 1. age: 18-65 2. diagnosed of hiv by lab confirmation 3. diagnosed of pml by diplomatic radiologists through brain mri or by brain biopsy once there are some concerns on radiologic diagnosis. 4. agree to sign the consent 5. agree to use contraception measures during 4 weeks before to 6 months after this study exclusion criteria: 1. pregnancy or lactating women or planing birth during this study 2. anticipated bad treatment compliance 3. within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)； 4. with neutrophil\<1000/mm3 or platelet\<75000/mm3 or allergic to pd-1 inhibitor 5）with severe basic diseases in heart, brain, lung, liver, kidney 6) disagree to sign the consent

Keywords: pd-1 inhibitor pembrolizumab progressive multifocal leukoencephalopathy aids
btc neuropsychological database

Conditions: Brain Tumor

Summary: purpose and objective: the purpose of this study is to collect data both retrospectively and prospectively, by consent, on subjects seen in the prtbtc. this information will be useful to the investigators to generate hypotheses for planning further psychosocial and medication intervention studies that will hopefully improve primary brain tumor patients' qol.

study activities and population group: retrospective dates will be 3/1/06 through the approval date for the prospective component of this study. the data will be neurocognitive, depression, tumor-related, overall quality of life (qol), treatment, and demographic variables. the investigators research aims are to * compute correlations among these different variables * to test significant predictors of qol. the investigators also will conduct a retrospective review of all brain tumor patients evaluated at the neuropsychology clinic at the prt-btc from the date that this prospective study is approved back to 3/20/2006. data analysis and risk/safety issues: the medical record review does not present any obvious source of risk or discomfort to patients and their families. for both the retrospective and prospective components of the study, as the data for the proposed study were already collected as a part of the standard of care at the preston robert tisch brain tumor center at duke, there are no additional risks to the study sample as a result of data collection.

Eligibility criteria:
inclusion criteria: * data collected both retrospectively and prospectively, by consent, on subjects with brain tumors seen in the preston robert tisch brain tumor center (prtbtc). * retrospective dates will be 3/1/06 through the approval date for the prospective component of this study. exclusion criteria: * n/a